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  • 1
    Publication Date: 2014-12-06
    Description: Introduction: Follicular lymphoma (FL) is the most common indolent non-Hodgkin lymphoma in the world and has a median age at diagnosis in the seventh decade. FL in young adults (YA; 40 years old or younger) is extremely rare. Currently, there are no standard approaches guiding treatment of YA patients with FL, and very little is known about disease characteristics and outcomes of YA patients with FL given limited research conducted in this vulnerable population. To gain further insight into FL in YA, we analyzed the National LymphoCare Study (NLCS) to describe disease and patient characteristics, as well as features of treatment in YA patients with FL. We previously reported that 2-year progression-free survival (PFS) is an important survival endpoint in patients with FL undergoing chemo-immunotherapy. Hence, we also sought to characterize 2-year PFS in this age group and compare it to older cohorts. Methods: Evaluablepatients were identified in the NLCS, and those between 18–40 years of age with newly diagnosed FL at any stage were classified as YA patients. Patients with mixed histology or transformed disease were excluded, as were patients with progression of disease prior to beginning first-line treatment. Survival probability was estimated by the Kaplan-Meier method. We estimated the association of age group with PFS using hazard ratios (HR) and 95% confidence intervals (CI) from multivariable Cox models. Results: A total of164 YA patients with FL were analyzed, representing 6.2% of the NLCS population, similar to the observed frequency in the Surveillance, Epidemiology, and End Results (SEER) Program data (4.8% of all FL). Sixty nine percent of YA patients had advanced stage disease. The majority of patients (80%) had low-grade histology, and 50% had good risk disease according to the Follicular Lymphoma International Prognostic Index (FLIPI). Nineteen percent of patients (31/164) underwent watchful waiting, 12% received rituximab monotherapy, and 47% received chemo-immunotherapy (61% of whom received R-CHOP [rituximab, doxorubicin, vincristine, prednisone]). There was no significant difference in FLIPI score or other baseline disease characteristics compared to adult patients aged 41–60 years. Eleven deaths occurred among YA with FL; only 5 of these were lymphoma related. Overall survival (OS) at 2 years was 97.4% (95% CI 93.3%, 99.0%), and at 5 years, 93.7% (88.3%, 96.7%), which was similar to patients aged 41–60 (97.2% [96.0%, 98.0%] at 2 years, and 92.0% [90.1%, 93.5%] at 5 years). After a median follow-up of 7.1 years, OS in YA FL was 92%. Through follow-up, there were 64 PFS events. The estimated 2-year PFS (95% CI) for YA and adults 41–60 was 75.9% (67.1%, 82.6%) and 80.9% (78.1%, 83.4%), respectively. After adjusting for FLIPI score, there was no difference in PFS for YA with FL requiring first-line treatment (excluding watchful waiting) compared to adults aged 41–60 years (HR=0.93; 95% CI 0.69, 1.25), and no difference in OS compared to adults aged 41–60 years (HR=1.19; 95% CI 0.64, 2.23). Conclusions: In the largest cohort of YA patients with FL to date, we found few differences in outcomes compared to patients aged 41–60. FLIPI and other disease characteristics were similar to adults aged 41–60 years. There were no differences between YA FL and adults aged 41–60 in PFS for all treated patients. OS in the YA group of patients with FL was outstanding. YA patients with FL have reassuringly similar outcomes to patients aged 41–60. Fertility preservation and survivorship issues should be taken into consideration when defining management strategies, but otherwise these data support that YA patients with FL should not be approached differently from older adults with the same disease. Disclosures Byrtek: Genentech, Inc.: Employment, Equity Ownership. Dawson:Genentech, Inc.: Employment, Equity Ownership. Zhou:RTI-HS: Employee of RTI-HS, which has research contracts with Genentech Other. Flowers:Seattle Genetics: Consultancy; Spectrum: Consultancy, Research Funding; Sanofi: Research Funding; Abbott: Research Funding; Novartis: Research Funding; OptumRx: Consultancy; Millennium/Takeda: Research Funding; Janssen: Research Funding; Celgene: Research Funding; Allos: Consultancy. Farber:Gilead: Speakers Bureau; Janssen/Pharmacyclics: Speakers Bureau; Seattle Genetics: Speakers Bureau; Leukemia Lymphoma Society NJ Chapter: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion: Speakers Bureau, Stock ownership Other. Cerhan:Genentech, Inc.: LymphoCare Scientific Advisory Board Other. Link:Genentech, Inc.: Consultancy, Scientific Advisory Board for Genentech Other.
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  • 2
    Publication Date: 2019-11-13
    Description: Introduction. The VES-13 is a simple, self-reported, function based tool originally developed to screen community-dwelling populations to identify persons age 65 years and older at risk of death and functional decline, including death in the next 12 months. The VES-13 items include patient's age, self-rated overall health status, functional limitations in physical activity, and functional disabilities in more complex activities of daily living. As part of the Lymphoma Epidemiology of Outcomes (LEO) cohort study, we collected self-reported VES-13 data at study enrollment on all participants regardless of age, and here we report on the prevalence of vulnerable status defined by the VES-13 and its association with 1-year mortality, overall, stratified at age 65 years, and in the subset of diffuse large B-cell lymphoma (DLBCL) treated with immunochemotherapy. Methods. From 7/2015 to 6/2017, 3253 participants with NHL were enrolled within 6 months of their diagnosis into the LEO cohort. 2004 were evaluable on VES-13, and 1183 (59%) completed it before the initiation of therapy. VES-13 scores range from a minimum of 0 (low risk for decline) to a maximum of 10 (greatest risk for decline), and a score ≥3 was classified as vulnerable. Clinical, pathology and treatment data were abstracted using a standard protocol, and participants were contacted every 6 months for the first three years and then annually thereafter to identify outcomes. Medical records were reviewed by LEO clinicians to classify cause of death according to a standard protocol. Therapy was determined by the treating physician, and this was independent of knowledge of the VES-13 score. The association of VES-13 with 1-year mortality from date of diagnosis was estimated using odds ratios (OR) and 95% confidence intervals (CI) from logistic regression models, which also provided model c-statistics. Results. The median age of the 2004 participants in this analysis was 62 years (range 18-94); 57% were male; 54% were ≥65 years; and 28% had a normal body mass index (BMI), 1% were underweight, 35% were overweight, and 36% were obese. Clinically, 59% of participants had an aggressive subtype, 65% were stage III-IV, 24% had B-symptoms, and 11% had a performance status (PS) of ≥2. Overall, 28% of participants were classified as vulnerable (95% CI 26%-30%), with a higher prevalence among those completing the survey after initiation of therapy (38%, 95% 34%-41%) versus before initiation of therapy (22%, 95% CI 20%-24%), and a higher prevalence for those ≥65 years (32%, 95% CI 29%-34%) versus
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  • 3
    Publication Date: 2014-08-21
    Description: Key Points Clinical responsiveness to imexon represents the first demonstration of efficacy with modulating cellular redox in B-cell NHL. Antioxidant-related gene expression predicted for response to imexon.
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  • 4
    Publication Date: 2019-05-02
    Description: Novel strategies, such as chemosensitization with targeted agents, that build on the success of standard immunochemotherapy show promise for the treatment of non-Hodgkin lymphoma (NHL). Here, we report a phase 1b study investigating dose escalation of the BCL2 inhibitor, venetoclax, in combination with rituximab or obinutuzumab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-/G-CHOP) chemotherapy in B-cell NHL. Objectives included safety assessment and determination of a recommended phase 2 dose (RP2D). Fifty-six patients were enrolled, most with follicular lymphoma (43%) or diffuse large B-cell lymphoma (DLBCL; 32%). Dose-limiting toxicities were reported in 3/14 patients at the first venetoclax dose (200 mg/d), after which dosing was changed from daily to 10 days per cycle and escalated to 800 mg. A further reduction to 5 days per cycle occurred at the 800-mg dose level in the G-CHOP arm. Cytopenias were predominant among grade 3/4 events and reported at a higher rate than expected, particularly in the G-CHOP arm; however, safety was manageable. Overall response rates were 87.5% (R-CHOP and G-CHOP combinations); complete response (CR) rates were 79.2% and 78.1%, respectively. Most double-expressor (BCL2+ and MYC+) DLBCL patients (87.5%; n = 7/8) achieved CR. Although the maximum tolerated dose was not reached, the RP2D for venetoclax with R-CHOP was established at 800 mg days 4 to 10 of cycle 1 and days 1 to 10 of cycles 2 to 8; higher doses were not explored, and this dosing schedule demonstrated an acceptable safety profile. This regimen is subsequently being evaluated in first-line DLBCL in the phase 2 portion of the study. This trial was registered at www.clinicaltrials.gov as #NCT02055820.
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  • 5
    Publication Date: 2009-11-20
    Description: Abstract 1956 Poster Board I-979 Background: Fluoro-deoxy-glucose positron emission tomography (FDG-PET) is a required staging study for diffuse large B-cell lymphoma and Hodgkin lymphoma. Numerous studies have demonstrated that FDG-PET performed after one to four cycles of multiagent chemotherapy (interim restaging) is predictive of outcome, with relapse rates much higher in patients with positive FDG-PET scans at interim restaging. The prognostic role of FDG-PET in T-cell lymphoma however is unclear and has yet to be well defined. Small retrospective studies have demonstrated FDG-PET avidity of T-cell lymphoma. Our experience confirms that the great majority of patients with mature T or NK lymphomas have FDG-PET avid disease. We hypothesized that the interim FDG-PET (int FDG-PET) may have prognostic importance in patients with T-cell lymphomas as they do in diffuse large B-cell lymphoma and Hodgkin lymphoma. Methods: We reviewed our T-cell lymphoma database to identify patients with mature T or NK lymphomas who had FDG-PET scans as part of complete staging at initial diagnosis as well as repeat PET imaging as part of restaging. Inclusion criteria required FDG-PET avid disease at baseline and treatment administered with curative intent. Results: We reviewed fifty four patients who met the above criteria. Histologies were as follows: peripheral T-cell lymphoma NOS (N=18), angioimmunoblastic T-cell lymphoma (N=5), anaplastic large cell lymphoma ALK-1- (N=15), anaplastic large cell lymphoma ALK-1+ (N=3), and other subtypes (N=13). Patients received a variety of initial chemotherapy regimens including CHOP (N=18), EPOCH (N=6), CHOP/ICE (N=20) or other treatments provided with curative intent. Twenty two patients were consolidated with high dose therapy and either autologous (N=18), or allogeneic (N=4) SCT. Fifty nine percent were PET negative at interim restaging (32/54), 7.4% were positive (4/54), 22 % were not available (12/54), and 11% had equivocal scans (6/54). Median follow up was 17 months. Median PFS for the entire group was 15 months. Median OS for the entire group was 40 months. The median OS of patients with negative int FDG-PET has not been reached, compared to the OS of patients with positive int FDG-PET of 10.2 months (p
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  • 6
    Publication Date: 2016-12-02
    Description: Introduction: Venetoclax (VEN) is a selective, potent oral BCL-2 inhibitor with clinical activity in patients (pts) with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL). In NHL xenograft models, VEN has enhanced efficacy of CHOP combined with either rituximab (R) or obinutuzumab (G). Methods: Dose escalation of VEN + R-CHOP (Arm A) or VEN + G-CHOP (Arm B) was evaluated in B-cell NHL pts with ≤1 prior therapies. Cohort 1 planned for VEN (200mg) on Cycle (C) 1 Day (D) 4, followed by daily administration for eight 21-day cycles. Cohorts 2-4 received VEN (400, 600 and 800mg) on C1 D4-10 and C2-8 D1-10; after the first 6 pts Arm B Cohort 4 dosing regimen was shortened to C1 D4-8 and C2-8 D1-5. CHOP was given for six 21-day cycles; R on D1 of C1-8 (Arm A); G on D1, 8, 15 of C1 and D1 of C2-8 (Arm B). Prophylaxis for tumor lysis syndrome (TLS) at the start of VEN dosing (including hospitalization for mass ≥10cm), mid-cycle complete blood counts, and G-CSF prophylaxis at the start of CHOP cycles were mandatory. Dose-limiting toxicities (DLTs) were assessed during C1-2, the defined DLT period. Objectives included safety, PK, determination of maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of VEN + R/G-CHOP, and response rate. Response was assessed by PET/CT Lugano criteria, with bone marrow (BM) clearance required for CR in case of baseline positivity. BCL-2 and Myc proteins were assessed by Immunohistochemistry and considered positive if ≥50% of tumor cells showed moderate to strong staining and ≥40% showed nuclear staining, respectively. Results: As of June 10, 2016, 56 pts were enrolled in Phase I; 91% were previously untreated. Histologies included: FL 24 (43%); DLBCL 17 (30%); MZL 5 (9%); composite lymphoma 5 (9%); and other 5 (9%). Three pts in Cohort 1 had DLT (Table 1), thus the VEN regimen was changed to C1 D4-10 and C2-8 D1-10 for Cohorts 2-4. No protocol-defined MTD was identified up to the maximum assessed dose (800mg) for either arm using intermittent dosing regimen. The most common AEs (all grades) in both arms were neutropenia (46%), nausea (45%), fatigue (38%), diarrhea (36%), and constipation (36%). The most common Gr 3/4 AEs were neutropenia (46%), febrile neutropenia (29%), and thrombocytopenia (TCP) (21%). Fifty out of 56 pts (93%) received G-CSF prophylaxis for neutropenia in C1. Three pts had laboratory TLS after the first VEN dose without any clinical sequelae, which resolved by no intervention (1) or medical intervention including holding dose (2). No cases of clinical TLS were observed. Excluding Cohort 1, Gr 4 laboratory TCP was more frequent in Arm B (8/25 pts; 32%) than Arm A (2/17 pts; 12%); in Cohorts 2-4, TCP occurred mid-cycle, with no associated clinically significant bleeding. As of the data cutoff, 46 pts completed study treatment, of which 33 completed VEN therapy (72%): 20 (83.3%) Arm A, 13 (59%) Arm B. Excluding Cohort 1 (6 pts discontinued VEN), all pts that discontinued VEN due to AEs were on Arm B. Reasons for early VEN discontinuation after Cohort 1 were TCP, pneumonia and sepsis; thus Arm B dose finding is ongoing. Thirty-eight of 46 pts completed CHOP therapy (82.6%): 21 (87.5%) Arm A, 17 (77.3%) Arm B; 7 pts discontinued due to AE and 1 progressive disease (PD) on C1 D5. Of the 42 pts in the intent-to-treat (ITT) analysis that were evaluable for efficacy response (≥1 cycles with available end of treatment (EOT) response assessment or discontinued prior to assessment), 18/21 (85.7%) in Arm A and 17/21 (81%) in Arm B had a response (Table 2). ITT analysis included 5 pts (1 pt Arm A, 4 pts Arm B) that discontinued study treatment early for toxicity (3 in Cohort 1). One pt (Arm A) discontinued study treatment on C1 D5 with PD and later died of PD following salvage chemotherapy. Of the Double Expressor (DE) DLBCL pts, 7/8 (87.5%) responded, 1/8 (12.5%) had a PD (Table 3). Median follow-up for pts with CR/PR at EOT response was 11 months. One of the pts that responded at EOT had progression during follow-up. Conclusions: VEN when administered for 10 days of the R-CHOP 21-day cycle had an acceptable safety profile. RP2D for VEN + R-CHOP is 800mg C1 D4-10 and C2-8 D1-10, given the acceptable incidence of DLTs. Phase 2 (only frontline DLBCL pts) is ongoing. VEN + G-CHOP dose finding is ongoing due to mid-cycle TCP. Response rates for VEN + R/G-CHOP are promising. High response rate was observed in the poor prognosis population of DE DLBCL. Updated EOT response, follow-up, and safety data will be presented at the meeting. Disclosures Zelenetz: Gilead Sciences: Research Funding. Salles:Amgen: Consultancy, Honoraria; Gilead: Honoraria, Research Funding; Novartis: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Roche/Genentech: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria; Mundipharma: Honoraria. Casulo:Infinity: Consultancy, Honoraria; Celgene: Research Funding. Sehn:roche/genentech: Consultancy, Honoraria; amgen: Consultancy, Honoraria; seattle genetics: Consultancy, Honoraria; abbvie: Consultancy, Honoraria; TG therapeutics: Consultancy, Honoraria; celgene: Consultancy, Honoraria; lundbeck: Consultancy, Honoraria; janssen: Consultancy, Honoraria. Cartron:Roche: Consultancy, Honoraria; Celgene: Honoraria; Gilead: Honoraria; Jansen: Honoraria. Chamuleau:Roche: Consultancy; Gilead: Consultancy; Celgene: Consultancy. Goy:infinity: Consultancy, Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Other: Writing support, Speakers Bureau; Acerta: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Tam:Gilead: Honoraria; Roche: Honoraria; Abbvie: Honoraria; Janssen: Honoraria. Lugtenburg:Celgene: Consultancy; Mundipharma: Consultancy; Servier: Consultancy; Roche: Consultancy; Takeda: Consultancy. Elstrom:Genentech: Employment. Farazi:Genentech: Employment. Liu:Roche: Employment. Szafer-Glusman:Genentech, Inc.: Employment. Mobasher:Genentech, Inc.: Employment. Morschhauser:Celgene: Consultancy, Honoraria; Gilead Sciences: Consultancy, Honoraria; Janssen: Honoraria; Roche: Consultancy, Honoraria; Servier: Consultancy, Honoraria.
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  • 7
    Publication Date: 2014-12-06
    Description: Introduction: Mantle cell lymphoma (MCL) is a heterogeneous disease and risk-stratification of patients (pts) for treatment is not performed routinely. For older pts ineligible for aggressive treatments, comprehensive geriatric assessments (CGA) are recommended but not routinely implemented into practice. Commonly used chemo-immunotherapeutic options result in low rates of complete remission (CR) (40%-50% bendamustine-rituximab; Rummel et al Lancet 2013; Flinn et al Blood 2014), with frequent relapses. Risk-stratification of older MCL pts through biological and clinical characteristics may improve treatment outcomes and reduce toxicity. Ofatumumab may have an advantage over rituximab given more efficient complement activation and complement dependent cytotoxicity. To test this we designed a phase II risk-stratified study of ofatumumab alone or in combination with bendamustine as first line treatment for elderly MCL with the goal of improved remission rates and extended survival. Methods: This was a single-institution phase II study. The primary objective was response. Eligible pts were 65 years of age or older with untreated MCL and/or ineligible for aggressive treatments such as high dose chemotherapy/autologous stem cell transplant. Patients were risk-stratified for therapy. Low risk pts with no GELF/NCCN criteria, low/intermediate risk MIPI, Ki-67 index 〈 30% and no blastic morphology received single agent ofatumumab weekly for 4 doses. High risk pts with GELF/NCCN criteria present, high risk MIPI, Ki-67 index 〉 30% or blastic morphology received ofatumumab and bendamustine (O-B) every 28 days for 6 cycles. A simon-two stage design was implemented requiring 6 of 12 pts to have a CR in the O-B arm to proceed. Pts receiving ofatumumab only were permitted to cross over to O-B for less than a partial response (PR) at restaging. Survival probability was estimated by the Kaplan-Meier method. CGA was performed prior to each cycle, and correlation to treatment toxicity was evaluated as a secondary endpoint. Results: Twenty pts in total were enrolled. Median age was 73 (range: 44-83). Seven pts (35%) were classified as low risk and received single agent ofatumumab. Thirteen pts (65%) were classified as high risk and received O-B. All patients in the O-B arm completed 6 cycles of treatment, all met GELF/NCCN criteria. Of these, 54% had high risk MIPI, 54% had Ki67 ≥30%. Among pts receiving single agent ofatumumab, 71% (5 pts) had 〈 PR (stable disease), 1 had CR (14%), and 1 pt was not evaluable. Three pts with 〈 PR crossed over to the O-B arm. Among 12/16 evaluable pts (3 too early, 1 withdrew) in the O-B arm; overall response rate was 92%; CR rate was 67%, PR rate 25%. One patient had stable disease (8%). After median follow-up of 1.8 years (range 0.1-2.6 years), overall survival in the entire group is 100%. Progression free survival at 2 yrs for the O-B arm is estimated at 68%. Both regimens were safe and well tolerated. Incidence of grade 3/4 serious adverse effects was 15% (3 of 22 patients), all in the O-B group. Baseline CGA identified patients as low (n=15) and medium risk (n=3) for grade 3/4 toxicity, with all three SAE (pneumonia, UTI, SVT) occurring in medium risk patients (p=0.001). Baseline timed-up and go showed a trend for anticipated toxicity for patients in the worst quartile (p=0.11). Conclusions: The combination of ofatumumab and bendamustine has promising activity in elderly pts with high risk MCL, with superior CR rates compared to historical chemo-immunotherapeutic regimens. Single agent ofatumumab had modest activity, but was safe in low risk pts and did not impact responses to chemoimmunotherapy. CGA assessment may help predict toxicity. Ofatumumab-bendamustine is effective as first line treatment for older pts with MCL and holds promise as a platform for combination with novel agents in prospective trials of untreated MCL. Figure 1 Figure 1. Disclosures Off Label Use: Ofatumumab is an anti CD20 monocloncal antibody not approved for use in mantle cell lymphoma. Moskowitz:Genentech: Research Funding; Merck: Research Funding; Seattle Genetics, Inc.: Consultancy, Research Funding. Zelenetz:Foundation Medicine, Inc: Consultancy. Hamlin:Seattle Genetics, Inc.: Consultancy, Research Funding.
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  • 8
    Publication Date: 2014-12-06
    Description: Background: Comprehensive Oncology Measures for Peripheral T-Cell Lymphoma Treatment (COMPLETE) is the largest registry of prospectively treated PTCL patients in the United States. Patients are enrolled at the initial diagnosis of PTCL and within 30 days of starting treatment. Data on demographics, clinical characteristics, diagnosis, therapy delivered as induction or salvage, and outcomes are collected. Methods: For this report, we examined baseline characteristics and induction treatment patterns for patients with the 3 most common subtypes of PTCL: PTCL not otherwise specified (NOS), anaplastic large cell lymphoma (ALCL) and angioimmunoblastic T-cell lymphoma (AITL). Only data from locked records are reported. Locked records are those that have been reviewed and digitally signed by the treating investigator. Results: Five hundred patients were enrolled from February 2010 until January 2014. As of July 2014, there were 257 locked baseline records and 188 locked treatment records for patients with a diagnosis of PTCL-NOS, ALCL or AITL. The mean age of these patients was 60 (range: 51-70). Most were male (66%) and white (78%). At study entry, 234 (91%) had an ECOG performance status of 0-1, 190 (74%) had Ann Arbor stage of III/IV, and 120 (47%) had one or more B symptoms. Half of the patients had extranodal disease. Mean international prognostic index (IPI) score was 2 (range 0-5). For staging, a PET/CT was the most common radiographic method used (58% of patients), and for pathologic diagnosis, on average, 10 phenotypic and ~1 genetic markers were assessed. For baseline characteristics reported here, patients treated at academic centers had more extranodal disease, a higher IPI score and tended to have more advanced disease compared to patients treated in the community. The primary intent of initial therapy was a cure for 89% of patients and 60% received an anthracycline or anthracycline plus etoposide-containing regimen. A minority of patients (21%) participated in a clinical trial for PTCL. Further details on induction therapy can be found in the table below. Table Initial Treatment Characteristics Total Academic Community Initial Treatment Approach* N=188 n=158 n=30 Induction chemotherapy (CT) alone 125 (66%) 102 (65%) 23 (77%) Induction CT + consolidation or maintenance 11 (6%) 10 (6%) 1 (3%) Stem cell transplant 36 (19%) 33 (21%) 3 (10%) Local radiotherapy +/- chemotherapy 10 (5%) 7 (4%) 3 (10%) Observation/best supportive care 6 (3%) 6 (4%) 0 (0%) Induction Regimens N=186 n=154 n=32 CHOP/CHOP-like 76 (41%) 56 (36%) 20 (63%) CHOP/CHOP-like + etoposide 37 (20%) 30 (20%) 7 (22%) Gemcitabine-based regimen 6 (3%) 6 (4%) 0 (0%) Platinum-based regimen 5 (3%) 5 (3%) 0 (0%) Other 62 (33%) 57 (37%) 5 (15%) Number of Cycles of Induction CT Median, Inter-Quartile Range (Cycles) 5 (2-6) 5 (2-6) 5 (1-6) Type of Transplant Performed N=36 n=33 n=3 Autologous 34 (94%) 31 (94%) 3 (100%) Allogeneic 2 (6%) 2 (6%) 0 (0%) *5 patients received CNS prophylaxis with selected treatments shown above CHOP=cyclophosphamide, doxorubicin, prednisone, and vincristine Conclusions: Early results from the first prospective US-based registry of newly diagnosed patients with PTCL-NOS, ALCL and AITL show that beyond CHOP-based therapy, there is little consensus on initial management of these patients. These data strongly support the need to develop evidence-based approaches for this rare and heterogeneous group of patients. Disclosures Pinter-Brown: Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Foss:spectrum: Research Funding; seattle genetics: Research Funding; Merck: Research Funding; Celgene: Honoraria, Research Funding; Millenium: Honoraria, Membership on an entity's Board of Directors or advisory committees. Carson:Spectrum: Consultancy; Celgene: Consultancy, Speakers Bureau. Horwitz:Celgene: Consultancy, Research Funding; Millennium: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Spectrum: Research Funding; Infinity: Research Funding; Kiowa-Kirin: Research Funding; Amgen: Consultancy; Bristol-Myers Squibb: Consultancy. Rosen:Allos: Consultancy, Honoraria. Gisselbrecht:Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Hsi:Daiichi-Sankyo: Consultancy; Allos: Research Funding; Seattle Genetics: Speakers Bureau; Eli Lilly: Research Funding; Abbott: Research Funding; Cellerant Therapeutics: Research Funding; BD Biosciences: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics: Research Funding. Lechowicz:Spectrum: Consultancy; Seattle Genetics: Consultancy; Janssen: Consultancy; Millennium: Consultancy. Smith:Allos/Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Kahl:Allos : Research Funding. Park:Teva: Research Funding; Seattle Genetics: Research Funding; Janssen: Travel funding, Travel funding Other.
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  • 9
    Publication Date: 2019-11-13
    Description: Introduction: The standard therapy for early stage, unfavorable risk Hodgkin lymphoma (HL) with disease bulk is combined modality therapy, typically 4-6 cycles of ABVD followed by 30Gy involved-site radiotherapy (ISRT) (Eich JCO 2010). In this pilot study with four sequential cohorts, we studied whether consolidative radiotherapy could be reduced or eliminated in early stage, unfavorable risk HL patients treated with brentuximab vedotin (BV) and AVD chemotherapy. In the first cohort, we demonstrated that BV+AVD and 30Gy ISRT had an acceptable safety profile without significant pulmonary toxicity and promising efficacy (Kumar Blood 2016). In subsequent cohorts, we tested whether the ISRT dose could be reduced to 20Gy (cohort 2), the RT field could be reduced with consolidation volume radiation (CVRT; cohort 3), and whether radiation therapy could be eliminated (cohort 4). Methods: Patients received 4 cycles of BV 1.2 mg/kg with AVD chemotherapy every 2 weeks, followed by 30 Gy ISRT in cohort 1, 20Gy ISRT in cohort 2, 30 Gy CVRT in cohort 3, and no radiotherapy in cohort 4. CVRT targets PET-negative residual masses greater than 1.5cm on post-chemotherapy CT imaging. Eligible patients in cohorts 1-2 included untreated stage I/II, classical HL with any one of the following unfavorable risk factors: bulky disease (MSK criteria: maximal transverse or coronal diameter 〉7 cm on CT), elevated ESR, extranodal involvement, 〉2 lymph node sites, or infradiaphragmatic disease. In cohort 3-4, early stage patients with bulky disease by MSK criteria were eligible. PET/CT after 2 and 4 cycles and after ISRT were interpreted with the 5-point Deauville scale (negative=1-3). The primary endpoint of cohort 1 was to evaluate safety and tolerability of the treatment combination, with special attention to pulmonary toxicity; the primary endpoint of cohorts 2-4 was to evaluate preliminary efficacy with the rate of complete responses (CRs) at end of treatment (EOT). Results: In June 2019, the study was fully accrued with 117 patients enrolled across four cohorts. Patients had a median age of 32 (range 18-59), 98% stage II, 86% with MSK-defined disease bulk (〉7cm in transverse or coronal dimension), 27% with traditionally defined bulk (〉10cm in transverse dimension), 50% elevated ESR, 38% B-symptoms, 21% extranodal involvement, 56% 〉2 involved lymph node sites, and 3.4% infradiaphragmatic disease. 26 patients (22%) had advanced stage disease by German Hodgkin Study Group criteria: IIBX (n=16), IIBE (n=5), and IIBXE (n=6). Of the patients enrolled in cohorts 1-3 with interim PET imaging, 85% and 91% achieved a negative PET scan after 2 and 4 cycles of therapy, respectively, and 95% achieved a CR at EOT. In cohort 4, 24 of the 29 enrolled patients have completed 4 cycles of therapy. Thus far, 93% of patients achieved a negative PET-2 scan (25 of 27 patients), 77% of patients achieved a negative PET-4 scan (17 of 22 patients), and 91% achieved a CR at EOT (20 of 22 patients). The remaining two patients with equivocal PET-4 results will have repeat short-interval scans to clarify EOT response. The overall median follow-up of survivors is 29 months: 56 months for cohort 1, 38 months for cohort 2, 24 months for cohort 3, and 5 months for cohort 4. Seven events have occurred in the study thus far. In cohort 1, two patients had primary refractory disease after chemotherapy and were treated off study. In cohort 2, one patient in remission died in a motor vehicle accident and one late relapse occurred at 34 months. In cohort 3, two patients had primary refractory HL after CVRT and one relapse occurred at 9 months. Overall, the 2-year PFS is 94% (95% CI 0.90, 0.99), see Figure. Across all 4 cohorts, the BV+AVD treatment was well-tolerated; the most common toxicities were peripheral neuropathy, abdominal pain, and neutropenia that were generally mild-moderate in severity, reversible, and manageable. Conclusion: BV+AVD x 4 cycles is an active treatment program for early stage, unfavorable risk HL, including patients with bulky disease. The efficacy of BV+AVD in this setting has facilitated a safe reduction in radiation dose and field evidenced by excellent and similar outcomes across the first 3 cohorts. With substantial follow-up, 20Gy ISRT appears equivalent to 30Gy ISRT following BV+AVD. The preliminary outcomes from the final cohort with chemotherapy alone are also promising, however, follow-up is short. Updated response data will be presented at the meeting. Disclosures Kumar: Seattle Genetics: Research Funding. Casulo:Gilead: Honoraria, Other: Travel, accommodation, expenses; Roche: Other: Travel, accommodation, expenses; Celgene: Research Funding. Advani:Kyowa Kirin Pharmaceutical Developments, Inc.: Consultancy; Cell Medica, Ltd: Consultancy; Kura: Research Funding; Merck: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Stanford University: Employment, Equity Ownership; Seattle Genetics: Consultancy, Research Funding; Agensys: Research Funding; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; Autolus: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Research Funding; Infinity Pharma: Research Funding; Forty-Seven: Research Funding; Gilead Sciences, Inc./Kite Pharma, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees; Regeneron: Research Funding; Janssen: Research Funding; Millennium: Research Funding; Roche/Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celmed: Consultancy, Membership on an entity's Board of Directors or advisory committees. Budde:F. Hoffmann-La Roche Ltd: Consultancy. Barr:Janssen: Consultancy; Astra Zeneca: Consultancy, Research Funding; Verastem: Consultancy; Gilead: Consultancy; AbbVie: Consultancy; Pharmacyclics LLC, an AbbVie company: Consultancy, Research Funding; TG Therapeutics: Consultancy, Research Funding; Celgene: Consultancy; Merck: Consultancy; Seattle Genetics: Consultancy; Genentech: Consultancy. Batlevi:Juno Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees. Friedberg:Acerta: Other: Data & Safety Monitoring Committee; Bayer: Honoraria, Other: Data & Safety Monitoring Committee. Horwitz:Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundipharma: Consultancy; Mundipharma: Consultancy; Aileron: Research Funding; Infinity/Verastem: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Innate Pharma: Consultancy; Innate Pharma: Consultancy; Seattle Genetics: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Astex: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Trillium: Research Funding; Celgene: Consultancy, Research Funding; Astex: Consultancy; Kyowa Hakko Kirin: Consultancy; Trillium: Research Funding; Affimed: Consultancy; Innate Pharma: Consultancy; Affimed: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Miragen: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astex: Consultancy; Celgene: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Kura: Consultancy; Kyowa Hakko Kirin: Consultancy; Kyowa Hakko Kirin: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Affimed: Consultancy; Miragen: Consultancy; Miragen: Consultancy; Portola: Consultancy; Trillium: Research Funding; Mundipharma: Consultancy; Portola: Consultancy; Astex: Consultancy; Aileron: Research Funding; Aileron: Research Funding; Celgene: Consultancy, Research Funding; Forty-Seven: Research Funding; Trillium: Research Funding; Forty-Seven: Research Funding; Forty-Seven: Research Funding; Aileron: Research Funding; Portola: Consultancy; ADCT Therapeutics: Research Funding; Affimed: Consultancy; Mundipharma: Consultancy; ADCT Therapeutics: Research Funding; ADCT Therapeutics: Research Funding; ADCT Therapeutics: Research Funding; Portola: Consultancy; Forty-Seven: Research Funding; Miragen: Consultancy; Kura: Consultancy; Kura: Consultancy; Kura: Consultancy; Kyowa Hakko Kirin: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding. Matasar:Genentech, Inc.: Consultancy, Honoraria, Other: Travel, accommodation, expenses , Research Funding; Bayer: Consultancy, Honoraria, Other; Roche: Consultancy, Honoraria, Other: Travel, accommodation, expenses , Research Funding; Merck: Consultancy, Equity Ownership; Juno Therapeutics: Consultancy; Teva: Consultancy; Rocket Medical: Consultancy, Research Funding; Bayer: Other: Travel, accommodation, expenses; Janssen: Honoraria, Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding; GlaxoSmithKline: Honoraria, Research Funding; Daiichi Sankyo: Consultancy; Seattle Genetics: Consultancy, Honoraria, Other: Travel, accomodation, expenses, Research Funding. Moskowitz:Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Merck: Research Funding; Takeda Pharmaceuticals: Consultancy; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Merck: Research Funding; Merck: Research Funding; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Erytech Pharma: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; Merck: Research Funding; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; ADC Therapeutics: Consultancy; Takeda Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Incyte: Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; ADC Therapeutics: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Erytech Pharma: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Erytech Pharma: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Cell Medica: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; Cell Medica: Consultancy; Cell Medica: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Cell Medica: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Merck: Research Funding; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; Cell Medica: Consultancy; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Takeda Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Merck: Research Funding; Erytech Pharma: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; Merck: Research Funding; Merck: Research Funding; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; ADC Therapeutics: Consultancy. Noy:Prime Oncology: Honoraria; NIH: Research Funding; Medscape: Honoraria; Janssen: Consultancy; Pharamcyclics: Research Funding; Raphael Pharma: Research Funding. Palomba:Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; STRAXIMM: Membership on an entity's Board of Directors or advisory committees; Kite Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Evelo: Equity Ownership; MSK (IP for Juno and Seres): Patents & Royalties; Noble Insights: Consultancy; Merck & Co Inc.: Consultancy; Seres Therapeutics: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Hemedicus: Speakers Bureau. Straus:Elsevier (PracticeUpdate): Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Hope Funds for Cancer Research: Membership on an entity's Board of Directors or advisory committees. Younes:Roche: Consultancy, Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Curis: Honoraria, Research Funding; Merck: Honoraria, Research Funding; Abbvie: Honoraria; Takeda: Honoraria; Pharmacyclics: Research Funding; AstraZeneca: Research Funding; Genentech: Research Funding; Biopath: Consultancy; Xynomics: Consultancy; Epizyme: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; HCM: Consultancy; BMS: Research Funding; Syndax: Research Funding. Zelenetz:Beigene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech/Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; MEI Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics/AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Verastem: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Morphosys: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics/AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Verastem: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; DAVA Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech/Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Beigene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; MEI Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Morphosys: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; DAVA Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moskowitz:ADC Therapeutics: Research Funding; Merck: Consultancy, Research Funding; Seattle Genetics, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; Celgene: Consultancy; Pharmacyclics: Research Funding.
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    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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  • 10
    Publication Date: 2019-11-13
    Description: INTRODUCTION Complete staging via bone marrow assessment is standard of practice for most newly diagnosed non-Hodgkin lymphoma (NHL) patients, though the methods and patterns of bone marrow assessment vary in clinical practice. The 2014 Lugano Classification recommends that in diffuse large B cell lymphoma (DLBCL), positron emission tomography-computed tomography (PET/CT) alone can designated advanced-stage disease in many, but not all cases. For most other NHL subtypes, obtaining bone marrow biopsy (BMB) remains recommended. We aimed to assess clinical practice patterns of marrow assessment and the performance of PET/CT in the clinical setting. METHODS The Lymphoma Epidemiology of Outcomes (LEO) cohort is a prospective cohort from 8 academic medical centers. All patients were enrolled in the cohort within 6 months of diagnosis, and prospectively followed. Patients with lymphoma enrolled in the cohort between July 2015 and June 2017 were included for study. Baseline clinical characteristics at diagnosis, whether BMB and/or PET/CT were performed, and the result of these assessments were extracted from the database. Bone marrow involvement on PET/CT was abstracted via review of radiology reports. No central review of images was utilized. RESULTS In total, 3,251 patients were included, consisting of the following subtypes: DLBCL (n=1,098), follicular lymphoma (FL n=730), mantle cell lymphoma (MCL n=302), T-cell lymphoma (TCL n=278), marginal zone lymphoma (MZL n=269), other NHL (n=505) and composite lymphoma (n=69). Other clinical characteristics are shown in table 1. Staging BMB was obtained in 78% of patients, PET/CT was obtained in 56%, both BMB and PET/CT were obtained in 46% while neither were obtained in 9% (table 1). There were significant differences in lymphoma subtype between patients having any bone marrow assessment vs no bone marrow assessment (p
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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